AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- In-stent binary angiographic restenosis rate
研究概览
简要总结
Chronically total occlusions (CTO) are difficult to treat and have high risk for restenosis. Although everolimus-eluting stents (EES) [(Xience, Abbott Vascular) or Promus (Boston Scientific)] are very promising for the treatment of CTOs due to their low late loss and excellent deliverability, there are currently no published data on EES implantation in CTOs.
The specific aim of this proposal is to examine the 8-month incidence of binary angiographic in-stent restenosis (defined as a stenosis of > 50% of the minimum lumen diameter of the target stent) after implantation of the EES in CTO.
It is the investigators hypothesis that EES-treated CTO lesions will have ≤ 20% 8-month in-stent binary angiographic restenosis rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Successful treatment of a native coronary artery CTO (defined as a lesion with 100% angiographic stenosis that is at least 3 months old as estimated by clinical information, sequential angiographic information, or both) using everolimus-eluting stents
- •Able and willing to return for angiographic follow-up after 8 months and to be followed clinically for 12 months
- •Agree to participate and provide informed consent
排除标准
- •Planned non-cardiac surgery within the following 12 months
- •Recent positive pregnancy test, breast-feeding, or possibility of a future pregnancy
- •Coexisting conditions that limit life expectancy to less than 12 months
- •Patients who have a creatinine above 2.5 mg/dL (unless they require hemodialysis, in which case they are eligible to participate)
- •History of an allergic reaction or significant sensitivity to everolimus
结局指标
主要结局
In-stent binary angiographic restenosis rate
时间窗: 8 months
次要结局
- Percent stent strut coverage, as assessed by optical coherence tomography(8 months)
- In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography(8 months)